FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Alere Acquires FDA CLIA Waiver for Alere I RSV Rapid Molecular Test

March 8, 2017
A A

Massachusetts–based Alere has been granted CLIA (clinical laboratory improvement amendments) waiver by the FDA for the detection of RSV (respiratory syncytial virus) infection in children and adults.

Alere i RSV detects the RSV virus in nasopharyngeal swab samples using Alere's proprietary Molecular In Minutes isothermal nucleic acid amplification technology.

The CLIA waiver allows the test to be made available in physician offices, hospital emergency rooms and walk-in clinics.

The test was FDA cleared in August 2016. — Cynthia Jessup

View today's stories